Manufacturing QMS Specialist

Kashiv Biosciences LLC; Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

FSA

HSA

Commuter/Transit Benefits

Student Loan Assistance Program

Monthly Cell Phone Allowance

Free Parking (Company Paid)

Conveniently located next to the Metra, Green and Red Line

Near Chicago White Sox Stadium

< 10 minutes away from Downtown Chicago

Job summary

Kashiv Biosciences LLC is seeking a Manufacturing QMS Specialist for a full-time position in Chicago, IL. The role involves supporting the manufacturing team with documentation, including reviewing batch records and filing change controls. Candidates should have at least a BA/BS in Biological Sciences and a minimum of 5 years of experience in biopharmaceuticals, along with strong communication and interpersonal skills. Benefits include medical, dental, vision, 401K, and more.

Qualifications

• Minimum BA or BS in Biological Sciences or related technical field is required.
• Minimum 5 years of experience in Biopharmaceuticals.
• Knowledge in USP and DSP process.

Responsibilities

• Support the manufacturing team with documentation work.
• Review batch records and file change controls.
• Use investigation tools for critical investigations.
• Attend daily meetings for documentation requirements.
• Meet weekly with QA to ensure timely QMS closure.
• Author batch records and related forms.
• Submit GMP documents to QA.

Skills

Interpersonal Skills

Communication Skills

Detail-oriented

Basic Computer Skills

Knowledge of GMP Documentation

Cleaning Verification/Validation Knowledge

Education

BA or BS in Biological Sciences or related field

5 years of experience in Biopharmaceuticals

Tools

Microsoft Word

Microsoft Excel

Job description

The Manufacturing QMS Specialist is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC. This position is located in Chicago, IL. Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will be executing routine documentation work which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs and more. This position requires technical expertise in the upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing).

Essential Duties & Responsibilities

• Will be responsible for supporting the manufacturing team with all kinds of documentation.
• Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record).
• Will be responsible for filing change controls, Deviation, and CAPA for manufacturing department.
• For all critical / major investigation, will have to use investigation tools like 5Why or 6M method.
• Attend daily meetings with both upstream and downstream process to get all the documentation requirements for the day.
• Will meet weekly with QA to avoid any delay in the QMS closure.
• Will author batch records, SOPs and associated forms / formats required for the manufacturing process.
• Will be responsible for requesting / submitting all GMP documents to QA.
• During critical campaign, will support manufacturing process (rotating shifts).
• Wet lab work will not be more than 10 % of your time.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Education

• A Minimum BA or BS in Biological Sciences or related technical field is required.
• Minimum 5 years of experience in Biopharmaceuticals.
• Knowledge in USP and DSP process.

Special Skills

• Ability to work with other team members and independently - good interpersonal skills.
• Good communication skills: verbal and written, good computer and organization skills, detail oriented.
• Basic computer skills, including knowledge of Word, Excel and spreadsheet.
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Knowledgeable in cleaning verification/validation.

Work Environment & Physical Demands

• Noise: No extraordinary noise levels.
• Standing/Lifting: No extraordinary requirements.
• Visual: No extraordinary requirements.
• Stress: High-paced demanding environment to meet ambitious project goals.
• Travel: None (some travel may be involved).

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed, work under pressure and meet deadlines. Some travel may be involved.

Supervisory Responsibility, if any

No

Benefits/Perks

• Medical
• Dental
• Vision
• 401K
• FSA
• HSA
• Commuter/Transit Benefits
• Student Loan Assistance Program
• Monthly Cell Phone Allowance
• Free Parking (Company Paid)
• Conveniently located next to the Metra, Green and Red Line
• One block east of the Chicago White Sox Stadium
• Less than 10 minutes away from Downtown Chicago

Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.